ALPCO Announces the European Commercial Launch of FDA 510(k) Cleared Calprotectin Immunoturbidimetric Assay and Patient Enrollment in Pivotal US Clinical Trial for Automated Chemiluminescent Version
The assay, which received FDA 510(k) clearance in 2023 and IVDD certification in 2022, is intended for in vitro diagnostic use to aid in the diagnosis of inflammatory bowel disease (IBD)—including Crohn's disease (CD) and ulcerative colitis (UC)—and to help differentiate IBD from irritable bowel syndrome (IBS) when used alongside other clinical and laboratory findings.
With a clinical sensitivity of 90.5% and specificity of 93.4%, the test offers high diagnostic accuracy and a low false positive rate. This enables healthcare providers to efficiently prioritize patients for colonoscopy, supporting faster diagnoses and more targeted care decisions.
In addition to expanding its offerings to the European market, ALPCO confirmed the first patient enrolled in its pivotal clinical trial for US FDA clearance of an automated chemiluminescent version of ALPCO's leading calprotectin assay, designed for use on the KleeYa™ system. ALPCO completed the FDA pre-submission process in March 2025, with clinical trial enrollment beginning in April. The company's calprotectin assays have been integral to ALPCO's success in the GI market and the chemiluminescent platform represents a significant advancement in automation, aiming to provide clinical laboratories with a streamlined, efficient, and scalable solution for calprotectin testing.
"We're thrilled to deliver a high-throughput GI test that is compatible with existing clinical chemistry analyzers while preserving accurate differentiation between IBD and IBS," said Erik Allen, CEO of ALPCO (A NuvinkaDx company). "In parallel, we're advancing our mission to deliver GI diagnostic solutions with greater automation and accuracy to clinical labs in the US."
This dual milestone—the European launch and the start of the pivotal US trial—underscores ALPCO's commitment to innovation and leadership in GI diagnostics.
About ALPCO and NuvinkaDx
ALPCO was founded in 1991 as an importer and distributor of immunoassay-based products for the North American life science markets. The company has since evolved into a leading producer of novel immunodiagnostic reagents for specialty testing laboratories. In 2022, ALPCO merged with GeneProof, a Czech Republic-based provider of specialty molecular diagnostic solutions. Founded in 2005, GeneProof offers a portfolio of more than 50 IVDD and 6 IVDR PCR test kits for infectious diseases and genetic mutations, as well as a suite of proprietary instrumentation for clinical laboratories of all sizes. In 2024 the holdings company for both organizations rebranded to NuvinkaDx. For additional information, please visit www.alpco.com and www.geneproof.com.
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